Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort

This study has been completed.

Study NCT00590590 Information provided by KV Pharmaceutical Company

First Received on December 26, 2007. Last Updated on March 18, 2011 History of Changes

Results First Received: June 30, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Vulvodynia
Interventions:	Drug: Lidocaine/Diphenhydramine Drug: lidocaine Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 31 physician offices in the US and Canada between 04Sep2007 to 18Mar2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants will undergo a screening period of two weeks prior to study assignment.

Reporting Groups

	Description
Lidocaine/Diphenhydramine (Combination)	Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
Lidocaine	Lidocaine administered twice weekly for 4 months
Placebo	Placebo administered twice weekly for 4 months

Participant Flow: Overall Study

	Lidocaine/Diphenhydramine (Combination)	Lidocaine	Placebo
STARTED	39	39	27
COMPLETED	32	33	21
NOT COMPLETED	7	6	6
Lack of Efficacy	1	2	0
Adverse Event	1	0	0
Protocol Violation	0	0	2
Lost to Follow-up	4	1	2
Withdrawal by Subject	0	1	1
Did not complete due to study closure	1	1	1
Did not complete study	0	1	0

Baseline Characteristics

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Reporting Groups

	Description
Lidocaine/Diphenhydramine (Combination)	Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
Lidocaine	Lidocaine administered twice weekly for 4 months
Placebo	Placebo administered twice weekly for 4 months

Baseline Measures

	Lidocaine/Diphenhydramine (Combination)	Lidocaine	Placebo	Total
Number of Participants [units: participants]	39	39	27	105
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	39	39	27	105
>=65 years	0	0	0	0
Age [units: years] Mean ± Standard Deviation	30 ± 7.4	32 ± 9.0	32 ± 9.5	31 ± 8.5
Gender [units: participants]
Female	39	39	27	105
Male	0	0	0	0
Region of Enrollment [units: participants]
United States	36	39	25	100
Canada	3	0	2	5

Outcome Measures

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1. Primary:

Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks) [ Time Frame: 12 weeks ]

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2. Secondary:

Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks) [ Time Frame: Baseline -12 Weeks ]

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3. Secondary:

Change From Baseline in Overall Vulvar Vestibulitis Syndrome (VVS)-Related Discomfort Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Discomfort and 100 = Most Severe Discomfort] [ Time Frame: 12 Weeks ]

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4. Secondary:

Change From Baseline in Overall Intercourse-Related Pain Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Pain and 100 = Most Severe Pain] [ Time Frame: 12 weeks ]

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5. Secondary:

Change From Baseline in Overall Vulvar Vestibulitis Symptoms Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Symptoms and 100 = As Bad as They Can be] [ Time Frame: 12 Weeks ]

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6. Secondary:

Change From Baseline in Tenderness (on a 0- to 3-point Scale) on Palpation at End of Treatment (12 Weeks) [Scale Rates the Severity of Pain; 0 =Absent and 3 = Severe] [ Time Frame: 12 Weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Investigator shall not publish, or seek to publish, either in whole or in part, any results of the Clinical Investigation without the written consent of the Sponsor.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was discontinued following enrollment of 106 of the planned 140 participants due to slow recruitment.

Results Point of Contact:

Name/Title: Chang Lee, MD Vice President Clinical and Medical Affairs
Organization: KV Pharmaceutical
phone: 314-645-6600
e-mail: clee@kvph.com

No publications provided

Responsible Party:	Chang Lee, MD Vice President Clinical and Medical Affairs, KV Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00590590 History of Changes
Other Study ID Numbers:	LDC-201-601-669020
Study First Received:	December 26, 2007
Results First Received:	June 30, 2010
Last Updated:	March 18, 2011
Health Authority:	United States: Food and Drug Administration